An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy

Anesthesia Clinical Trial

Official title:

A Phase 3, Randomized, Double-Blind, Dose-Controlled Study To Assess The Efficacy And Safety Of AQUAVAN® (Fospropofol Disodium) Injection For Minimal-To-Moderate Sedation In Patients Undergoing Flexible Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306722
• Other study ID #: 3000-0524
• Secondary ID: MGI 3000-0524
• Status: Completed
• Phase: Phase 3
• First received: March 22, 2006
• Last updated: November 6, 2008
• Start date: April 2006
• Est. completion date: May 2007

Study information

• Verified date: November 2008
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Very often patients receive medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild-to-moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol with a longer duration of effect.

Description:

This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of AQUAVAN 6.5 mg/kg compared to a minimally effective dose of AQUAVAN 2.0 mg/kg, both following pretreatment with an analgesic, fentanyl in patients who are undergoing flexible bronchoscopy.

Following completion of preprocedure assessments, patients will be randomly assigned to 1 of 2 treatment groups at a 2:3 (AQUAVAN initial dose 1 [2.0 mg/kg]:AQUAVAN initial dose 2 [6.5 mg/kg] allocation ratio on the day of the scheduled procedure. Randomization will be stratified by site.

A person skilled in airway management (such as a respiratory therapist, a study nurse, or a clinician) and authorized by the facility in which the colonoscopy is performed must be immediately available during the conduct of the study. All patients will be placed on supplemental oxygen via nasal cannula (4 L/min), and an ECG monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of study medication. All patients will receive analgesic pretreatment (fentanyl citrate injection for pain; lidocaine for topical anesthetic followed by the administration of study medication. Assessments will be made to evaluate the patients for levels of sedation, clinical benefit of sedation, and adverse events. Blood samples will be collected for PK analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures

2. Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study.

3. Patient must be at least 18 years of age at the time of screening.

4. If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predose.

5. Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4.

Exclusion Criteria:

1. Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid.

2. Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline.

3. Patient has a Mallampati Classification Score of 4; OR a Mallampati Classification Score of 3 AND a thyromental distance =4 cm, or for any other reason has a difficult airway, in the opinion of the Investigator.

4. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0.

5. Patient has participated in an investigational drug study within 1 month prior to study start.

6. Patient is unwilling to adhere to pre- and postprocedural instructions.

7. Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anesthesia
• Bronchoscopy

Intervention

Drug:
• AQUAVAN® (fospropofol disodium) Injection

Locations

Country	Name	City	State
United States	Johnston Memorial Hospital Pulmonary Research	Abingdon	Virginia
United States	Central Maine Pulmonary Associates	Auburn	Maine
United States	Acute Care Consultants Inc.	Augusta	Georgia
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	Keith Popovich, MD, PLLC	Butte	Montana
United States	Lowcountry Lung & Critical Care, PA	Charleston	South Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Cincinnati, The University Hospital	Cincinnati	Ohio
United States	Hurley Medical Center	Flint	Michigan
United States	Pulmonary Associates of Fredericksburg, Inc.	Fredericksburg	Virginia
United States	The University of Texas Medical Branch Division of APICS	Galveston	Texas
United States	Brody School of Medicine	Greenville	North Carolina
United States	Greenville Hospital System	Greenville	South Carolina
United States	United Health Scrvices Hosptial, INC	Johnson City	New York
United States	Saddleback Memorial Medical Center	Laguna Hills	California
United States	USC Health Science Campus (USC University Hospital)	Los Angeles	California
United States	International Heart Institue of MT Foundation	Missoula	Montana
United States	Pulmonary Associates of Mobile, PC	Mobile	Alabama
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Pensacola Research Consultants, Inc.	Pensacola	Florida
United States	Precision Trials	Phoenix	Arizona
United States	Berkshire Medical Center	Pittsfield	Maryland
United States	South Carolina Pharmaceutical Research	Spartanburg	South Carolina
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	ALL-TRIALS Clinical Research, LLC	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sedation Success rate is defined as: Having 3 consecutive Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale scores of =4 after administration of sedative medication
Primary	Completing the procedure
Primary	Without requiring the use of alternative sedative medication
Primary	Without requiring manual or mechanical ventilation
Secondary	Treatment Success rate - Treatment Success is defined as a patient (i) completing the procedure (ii) without requiring alternative sedative medications AND (iii) without requiring manual or mechanical ventilation
Secondary	Proportion of patients willing to be treated again with the same study sedative medication
Secondary	Proportion of patients who do not recall being awake during the procedure